The company is looking to strategically plan and direct clinical research activities involving investigational compounds in Immunology, with a focus on late-stage development. This involves managing the entire cycle of clinical development from study design to regulatory filing and publication.
Requirements
- Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology)
- Demonstrated record of scientific scholarship and achievement
- Clinical Development
- Clinical Medicine
- Clinical Research Management
- Clinical Studies
- Clinical Trial Development
Responsibilities
- Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.
- Developing clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategies.
- Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs.
- Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and
- Participation in internal and joint internal/external research project teams relevant to the development of new compounds
- Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies
- Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational drugs in Immunology.
Other
- Supervise the activities of Clinical Scientists in the execution of clinical studies.
- Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
- Establishing collaborative relationships with external experts in Rheumatology, Gastroenterology, Dermatology, and pulmonary disease, particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational drugs.
- Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
